Lotronex is a popular prescription drug introduced in the United States in 2000 for the treatment of irritable bowel syndrome. The irritable bowel syndrome condition affects women often associated with frequent diarrhea but sometimes the patients suffer severe constipation. The first approval of Lotronex use by patients with severe diarrhea condition was in 2000. However, the drug was under restricted use due to the potential side effects it had on patients.
Reports of Lotronex causing ischemic colitis; a fatal condition where intestinal blood circulation is restricted and severe constipation experienced by some patients, led to its withdrawal from market. The drug works on the colon receptors stopping the action of serotonin in the gut and thus decreases the bowl movement. The reduction in bowel movement allows normal functioning of the gut and thus prevents severe diarrhea condition.
The Food and Drug Administration (FDA) re-approval of the restricted use of Lotronex by women with severe diarrhea condition was because of the potential benefits of the drug over its adverse effects. Evidence shows that, the drug has adverse effects on patients and can be fatal sometimes. The re-introduction of the drug comes with new guidelines regarding its prescription to prevent any potential harmful effects like constipation (Avorn 448).
Medical practitioners approved by GlaxoSmithKline; the manufacturer of the drug can prescribe Lotronex to patients. With the re-approval of the drug, the company intends to resume production and at the same time, monitor the prescribing programs of the drug to avoid adverse effects experienced earlier on.
The opponents of the re-introduction argue that, the medication caused deadly effects to the patients the first time and currently there is no enough evidence to support its effectiveness in treatment of the severe diarrhea condition. Clinical trials did not prove the potency of the drug and thus other people propose alternatives to Lotronex like change of diet as proposed by Dr. Sidney Wolfe. Others hold the view that FDA erred in allowing GlaxoSmithKline to oversee the prescribing program.
The prescribing program aims at reducing the risks of adverse colon reactions. The lack of effective guidelines caused the adverse effects experienced during the first introduction of the prescription drug in the market. However, opponents of the reintroduction led by Dr. Wolfe believe that, Lotronex is not effective and is just like a placebo; that is, a medical intervention where an in inert pill brings about healing instead of the real medicine.
FDA again approved the usage of another potentially harmful drug called thalidomide but later withdrew it because it caused adverse birth defects like stunted features. Prescription drugs are normally licensed medicine whereby their use is regulated by various legislations as opposed to the over the counter drugs whose purchase and use is unregulated. However, according to Katzung, “In Canada and Europe, thalidomide is a prescription drug used as a sedative for morning sickness in pregnant women” (232).
Sedatives cause hypnotizing effects to the users by stimulating the target receptors thus reducing their effects. Most of these drugs are serotonin antagonists; that is, they work to inhibit the action of serotonin, a neurotransmitter primarily found in the gastrointestinal tract and the central nervous system of animals and humans. By inhibiting serotonin, the likes of lotronex affect the nervous system and consequently influence the normal functioning of body organs.
Works Cited
Avorn, Jerry. Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, Random House, 2004.
Katzung, Bertram. Basic and Clinical Pharmacology. New York: McGraw Hill Co, 2001.